Pharmacy Memo dated March 16, 2016



|[pic] | |[pic] |

| |Division of Medical Services | |

| |Pharmacy Program | |

| | | |

| |P.O. Box 1437, Slot S415 · Little Rock, AR 72203-1437 | |

| |Phone: 501-683-4120 · Fax: 1-800-424-5851 | |

MEMORANDUM

TO: Arkansas Medicaid Enrolled Prescribing Providers and Pharmacy Providers

FROM: Jason Derden, Pharm.D. Division of Medical Services Pharmacy Program [pic]

DATE: March 16, 2016

SUBJ: AR Medicaid PA edits approved at the AR Medicaid DUR Board January 20, 2016 meeting:

Changes To Existing Prior Authorization (PA) Criteria Or Edits: CIPRODEX® OTIC SUSPENSION changed to NO PA; generic OFLOXACIN otic drops will require Manual PA; Long-Acting Or Depot Formulation Antipsychotic Injectable Agents, including ABILIFY® MAINTENA™ (aripiprazole), ARISTADA™ (aripiprazole lauroxil), IVEGA SUSTENNA® (paliperidone palmitate), RISPERDAL CONSTA® (risperidone), ZYPREXA® RELPREVV™ (olanzapine pamoate), haloperidol decanoate inj., fluphenazine decanoate injection; All SHORT-ACTING OPIOID AGENTS in tablet or capsule form;

Clinical edits through the Manual Review PA Process: HCV Treatment HARVONI® (ledipasvir and sofosbuvir); HUMIRA® (adalimumab) injection when used for treating HS; ODOMZO® (sonidegib) 200 mg capsules; LONSURF® (trifluridine and tipiracil) tablets 20 mg/8.19 mg and 15 mg/6.14 mg; GLEOSTINE™ (lomustine) capsules 100 mg, 40 mg, 10 mg, 5 mg; TAGRISSO™ (osimertinib) tablets , 80 mg, 40 mg; COTELLIC™ (cobimetinib) tablets 20 mg; VELTASSA™ (patiromer) powder for oral suspension;

All criteria for the point of sale (POS) clinical edits and claim edits can be viewed on the Medicaid website at

(Reimbursement rates stated in this memo are informational only and current as of the writing of this memo; the rates are approximate as they have been rounded)

REVERSE AND CREDIT MEDICAID PRESCRIPTIONS NOT PROVIDED TO BENEFICIARY: Pharmacies are required to reverse and credit back to Medicaid original prescriptions and refills if the medication was not provided to the beneficiary. Pharmacies should reverse and credit Medicaid within 14 days of the date of service for any prescription that was not provided to the beneficiary. See the Provider Manual Update Transmittal or the Pharmacy Provider Manual Section 213.200.

CHANGE In Angiotensin II Receptor Blocker (ARB) PDL Preferred Drug Selection: Effective Feb. 15, 2016, the brand name DIOVAN® (valsartan) will move to non-preferred status. The MAC’d generic valsartan will become preferred status on Feb.15, 2016.

REMINDER REGARDING INCARCERATED PERSONS: The Medicaid Pharmacy Program is prohibited by federal regulations, 42 C.F.R. §435.1009 and §435.1010, from paying for drug claims for Medicaid beneficiaries who, on the date the prescription is filled, are incarcerated in a correctional or holding facility for individuals who are prisoners, including juvenile correctional facilities, are detained pending disposition of charges, or are held under court order as material witnesses.  If medications are requested for incarcerated Medicaid beneficiaries, including beneficiaries in a juvenile correctional facility, the medications cannot be billed to Medicaid Pharmacy Program and are subject to recoupment if billed to Medicaid.  Pharmacists should contact the correctional facility regarding the facility’s reimbursement procedures for the requested medications.  

REMINDER ABOUT DISPENSING USING EMERGENCY OVERRIDE: In an emergency, for those drugs for which a five-day supply can be dispensed, an enrolled pharmacy provider may dispense up to a five-day supply of a drug that requires a prior authorization, e.g., a drug that requires a clinical PA or a PA for a non-preferred drug. This provision applies only in an emergency situation when the MMA Prescription Drug Help Desk is unavailable, EBRx Call Center is unavailable, the state Medicaid Pharmacy Program office is closed, and the pharmacist is not able to contact the prescribing provider to change the prescription.

To submit a claim using this emergency provision, the pharmacy provider must submit “03” in the Level of Service (418-DI) field. Frequency of the emergency override is limited to once per year per class of drugs for non-LTC-eligible beneficiaries and once per 60 days per class for LTC-eligible beneficiaries. For any Schedule-II controlled substance filled using the Medicaid Emergency Override process, please refer to the Arkansas State Board of Pharmacy regulations regarding partial fill of a Schedule-II controlled substance. See information posted on the Medicaid Pharmacy Program website, .

1. CHANGES TO EXISTING POINT OF SALE PRIOR AUTHORIZATION (PA) CRITERIA OR EDITS:

A. CHANGES IN PA STATUS FOR CIPRODEX® OTIC SUSPENSION AND GENERIC OFLOXACIN OTIC SOLUTION:

Effective immediately, CIPRODEX® OTIC SUSPENSION will no longer require prior approval.

Effective June 7, 2016, generic OFLOXACIN OTIC Solution will require MANUAL REVIEW PA due to the steep increase in price and the drug availability by only one manufacturer. In addition, Ofloxacin ophthalmic drops are available at point-of-sale with no PA required. Prescribers may use the ophthalmic drops if deemed appropriate for the recipient's medical condition.

Magellan Medicaid Administration (MMA) Help Desk at 1-800-424-7895 or fax letter of medical necessity along with any documentation to substantiate the medical necessity of the request to 1-800-424-7976.

THE FOLLOWING EDITS WILL BE EFFECTIVE APRIL 26, 2016, UNLESS OTHERWISE STATED

B. LONG-ACTING INJECTABLE (LAI) ANTIPSYCHOTIC AGENTS, INCLUDING DEPOT FORMULATION, including ABILIFY® MAINTENA™ (aripiprazole), ARISTADA™ (aripiprazole lauroxil), IVEGA SUSTENNA® (paliperidone palmitate), RISPERDAL CONSTA® (risperidone), ZYPREXA® RELPREVV™ (olanzapine pamoate), haloperidol decanoate ampule or vial., fluphenazine decanoate vial: All references to LAI antipsychotic agents will include the antipsychotic depot formulations.

For adults who are ≥ 18 years of age, the point-of-sale approval criteria for the long-acting injectable (LAI) antipsychotic agents have been revised as follows:

• All existing point-of-sale approval criteria used for switching from an oral antipsychotic agent to a LAI antipsychotic will be removed.

• ARISTADA™ (aripiprazole lauroxil) currently requires a manual review PA and will also be added to the point-of-sale continuation criteria.

• All requests for any LAI antipsychotic agent for new starts and re-starts for beneficiaries who do not meet the point-of-sale continuation criteria for a LAI antipsychotic agent will be reviewed through a manual review prior authorization (PA) process. The prescriber must submit a letter explaining the medical necessity of starting or re-starting a LAI antipsychotic, and submit chart notes to substantiate the request.

• Existing continuation criteria will remain in effect that will allow the LAI antipsychotic claim to continue to pay at point-of-sale if there is a claim for the same LAI antipsychotic in Medicaid history in the previous 45 days.

• Concurrent therapy with more than one LAI antipsychotic agent will reject at point of sale.

• Adults who are ≥ 18 years of age may receive the oral antipsychotic formulation without prior authorization.

• Invega Trinza criteria have not changed and will continue to require manual review PA using the established PA form.

Below is a partial list of antipsychotic agents that only includes those drugs that have both a LAI form and an oral form of the same drug. This list compares the reimbursement rate of the oral and the LAI antipsychotic agent.

|DRUG |EAC calculated |MAC payment rate per |Approximate Reimbursement Rate|

| |payment rate for |each (Rounded) |and Monthly Quantity (ROUNDED|

| |EACH tablet or | |to nearest whole dollar) |

| |syringe (Rounded) | | |

|paliperidone ER (same as Invega® ER) 1.5 mg, 3 mg, 6 mg |$24.45 |Generic will be MAC’d|$758 / #31 tabs |

|tablets | |soon | |

|DRUG |EAC calculated |MAC payment rate per |Approximate Reimbursement Rate|

| |payment rate for |each (Rounded) |and Monthly Quantity (ROUNDED|

| |EACH tablet or | |to nearest whole dollar) |

| |syringe (Rounded) | | |

|Invega® ER (paliperidone ER) 1.5 mg, 3 mg, 6 mg tablets |$32 |N/A |$996/ #31 tablets |

|paliperidone ER (same as Invega® ER) 9 mg tablet |$36.68 |Generic will be MAC’d |$1,137 / #31 tabs |

| | |soon | |

|Invega® ER (paliperidone ER) 9 mg tablet |$48 |N/A |$1,494 / #31 tablets |

|Invega® (paliperidone) Sustenna 39 mg syringe |$363 |N/A |$363 / #1 syringe |

|Invega® (paliperidone) Sustenna 78 mg syringe |$725 |N/A |$725 / #1 syringe |

|Invega® (paliperidone) Sustenna 117 mg syringe |$1,088 |N/A |$1,088 / #1 syringe |

|Invega® (paliperidone) Sustenna 156 mg syringe |$1,450 |N/A |$1,450 / #1 syringe |

|Invega® (paliperidone) Sustenna 234 mg syringe |$2,175 |N/A |$2,175 / #1 syringe |

|Invega® (paliperidone) Trinza 273 mg syringe |$2,175 |N/A |$2,175 per 3 months |

|Invega® (paliperidone) Trinza 410 mg syringe |$3,263 |N/A |$3,263 per 3 months |

|Invega® (paliperidone) Trinza 546 mg syringe |$4,351 |N/A |$4,351 per 3 months |

|Invega® (paliperidone) Trinza 819 mg syringe |$6,526 |N/A |$6,526 per 3 months |

|risperidone 0.25 mg, 0.5 mg , 1 mg tablet |N/A |$0.19 |$12 / #62 tabs |

|risperidone (same as Risperdal®) 2 mg tablet |N/A |$0.30 |$19 / #62 tabs |

|risperidone (same as Risperdal®) 3 mg tablet |N/A |$0.33 |$20 / #62 tabs |

|risperidone (same as Risperdal®) 4 mg tablet |N/A |$0.42 |$26/ #62 tabs |

|Risperidone ODT (same as Risperdal® M-tab) 0.25 mg tablet |$3.84 |  |$238 / #62 tabs |

|risperidone ODT (same as Risperdal® M-tab) 0.5 mg tablet |N/A |$1.74 |$108 / #62 tabs |

|risperidone ODT (same as Risperdal® M-tab) 1 mg tablet |N/A |$3.29 |$204 / #62 tabs |

|risperidone ODT (same as Risperdal® M-tab) 2 mg tablet |N/A |$3.21 |$199 / #62 tabs |

|risperidone ODT (same as Risperdal® M-tab) 3 mg tablet |N/A |$7.09 |$439 / #62 tabs |

|risperidone ODT (same as Risperdal® M-tab) 4 mg tablet |N/A |$10.68 |$662 / #62 tabs |

|Risperdal (risperidone) Consta® 12.5 mg/ 2 ml |$198 |N/A |$396 /2 syringes per mo. |

|Risperdal (risperidone) Consta® 25 mg/ 2 ml |$396 |N/A |$792 /2 syringes per mo. |

|Risperdal (risperidone) Consta® 37.5mg/ 2 ml |$594 |N/A |$1,188 /2 syringes per mo. |

|Risperdal (risperidone) Consta® 50 mg/ 2 ml |$792 |N/A |$1,584 /2 syringes per mo. |

|aripiprazole (same as Abilify®) 2 mg, 5 mg, 10 mg, 15 mg |N/A  |$7.44 |$231/ #31 tabs |

|tablet | | | |

|aripiprazole (same as Abilify®) 20 mg, 30 mg tablet |N/A  |$10.20 |$316/ #31 tabs |

|Abilify Discmelt® (aripiprazole) 10 mg, 15 mg |$37 |N/A |$1,132 / #31 tabs |

|aripiprazole ODT(same as Abilify Discmelt®) 10 mg, 15 mg |$31 |N/A |$946 / #31 tabs |

|Abilify® (aripiprazole) Maintena 300 mg vial or syringe |$1,324 |N/A |$1,3224 / #1 inj. per mo. |

|Abilify® (aripiprazole) Maintena 400 mg vial or syringe |$1,765 |N/A |$1,765 / #1 inj. per mo. |

|Aristada™ (aripiprazole) injection 441 mg/1.6 ml |$1,088 |N/A |$1,088 /per month |

|Aristada™ (aripiprazole) injection 662 mg/2.4 ml |$1,634 |N/A |$1,634/ per month |

|Aristada™ (aripiprazole) injection 882 mg/3.2 ml |$2,176 |N/A |$2,176/ per month |

|olanzapine (same as Zyprexa®) 2.5 mg tablet |N/A |$0.35 |$11/ #31 tabs |

|olanzapine (same as Zyprexa®) 5 mg tablet |N/A |$0.39 |$12 /#31 tabs |

|olanzapine (same as Zyprexa®) 7.5 mg tablet |N/A |$0.45 |$14 /#31 tabs |

|olanzapine (same as Zyprexa®) 10 mg tablet |N/A |$0.54 |$17 /#31 tabs |

|olanzapine (same as Zyprexa®) 15 mg tablet |N/A |$0.77 |$24 / #31 tabs |

|olanzapine (same as Zyprexa®) 20 mg tablet |N/A |$0.98 |$30 /#31 tabs |

|olanzapine ODT (same as Zyprexa® Zydis) 5 mg tablet |N/A |$2.52 |$78 /#31 tabs |

|olanzapine ODT (same as Zyprexa® Zydis) 10 mg tablet |N/A |$3.51 |$109 /#31 tabs |

|olanzapine ODT (same as Zyprexa® Zydis) 15 mg tablet |N/A |$5.05 |$157 /#31 tabs |

|olanzapine ODT (same as Zyprexa® Zydis) 20 mg tablet |N/A |$7.05 |$218 / #31 tabs |

|Zyprexa® (olanzapine) Relprevv 210 mg vial |$707.62 |N/A |$1,415 / 2 vials per month |

|Zyprexa® (olanzapine) Relprevv 300mg vial |$1,010.88 |N/A |$2,022 / 2 vials per month |

|Zyprexa® (olanzapine) Relprevv 405 mg vial |$1,364.69 |N/A |$1,365 / 1 vial per month |

Magellan Medicaid Administration (MMA) Help Desk at 1-800-424-7895 or fax letter of medical necessity along with any documentation to substantiate the medical necessity of the request to 1-800-424-7976.

C. ALL SHORT-ACTING OPIOID PAIN AGENTS IN TABLET, ODT, OR CAPSULE FORMULATION:

For non-malignant acute or chronic pain, the accumulation quantity edit is decreased to a maximum of 93 tablets per previous 31-calendar days. For acute pain, the daily quantity edit limit that will allow up to 6 units per day will remain; however, the total accumulated quantity for the previous 31 calendar days cannot exceed 93 units. The system will continue to add the quantity from each short-acting opioid drug claim and if the incoming claim will cause the accumulated quantity to exceed 93 units in the previous 31 days, the incoming claim will reject.

Other short-acting opioid formulations, such as liquid, injectable agents, and nasal sprays, are not included in the revised quantity edit at this time; however, the therapeutic duplication edits between any two short-acting opioid agents will remain in effect, including tramadol-containing agents, injections, nasal formulations, solid oral dosage formulations and ODT formulations.

The short-acting opioid edits remain unchanged for beneficiaries with a malignant cancer diagnosis in the previous year if identified in the Medicaid system with one or more of the ICD-9 or ICD-10 diagnosis codes that match the diagnosis codes in the PA criteria list.

In addition, the therapeutic duplication edits between all forms of opioid agents, both short-acting and long-acting opioids, and the buprenorphine-containing agents used for treatment of opioid dependency, have been revised to lengthen the time between the claim date of a buprenorphine-containing agent and when an opioid agent will be paid by Medicaid. If a beneficiary has a claim for buprenorphine or buprenorphine-containing agent in Medicaid drug profile history within the previous 90 days, an incoming claim for an opioid agent will reject at point-of-sale.

Magellan Medicaid Administration (MMA) Help Desk at 1-800-424-7895 or fax letter of medical necessity along with any documentation to substantiate the medical necessity of the request to 1-800-424-7976.

THE FOLLOWING EDITS WILL BE EFFECTIVE IMMEDIATELY

2. NEW AND REVISED CLINICAL EDITS THROUGH MANUAL REVIEW PRIOR APPROVAL (PA) PROCESS:

A. HCV TREATMENTS: HARVONI® (ledipasvir and sofosbuvir tablet):

HARVONI® (ledipasvir and sofosbuvir tablet) is now indicated for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 hepatitis C infection. In addition, HARVONI®+ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin. The daily dosage of ribavirin is weight-based (1000 mg for patients ................
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